FDA 510(k)

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

Numéro K : K191933 · 2019-08-16

DemandeurJohnson & Johnson Surgical Vision, Inc.

Date de décision2019-08-16

Code produitHQC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191933. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K191933.

When did COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal receive FDA 510(k) clearance?

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191933.

Who is the listed applicant for COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

The FDA 510(k) record lists Johnson & Johnson Surgical Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal?

The FDA product code for COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal is HQC.

Essais cliniques associés

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Dispositifs connexes (Code : HQC)

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Source officielle

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